Who is the manufacturer of ARCPM 1050 RESIN-HIPS?

Biomet Orthopedics, Inc. filed the 510(k) submission for ARCPM 1050 RESIN-HIPS (K023357).

What is the FDA product code for ARCPM 1050 RESIN-HIPS?

LPH. It is classified under 21 CFR 888.3358 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ARCPM 1050 RESIN-HIPS?

510(k) clearance (submission type: Special).

What are the predicate devices for ARCPM 1050 RESIN-HIPS?

Ringloc UHMWPE Hi-Wall (K920640, K926107, K950761); Ringloc UHMWPE 10° (K920640, K926107, K950761); RX 90 std. Hi-Wall (K920639, K926107); RX 90 +5 Deep (K920639, K926107); Impact Hi-Wall (K921274); Mod. Hi-Wall LNR (K926107); Mod. 10° LNR (K926107); Ringloc LP Hi-Wall Arcom (K950761); Ringloc Arcom LP 10° (K950761); Arcom +5mm (K954417, K970501); Arcom Std. Face (K950761, K954417, K970501); Arcom Hi-Wall (K950761, K954417, K970501); Arcom 10° (K950761, K954417, K970501); Arcom 10° Hi-Wall (K950761, K954417, K970501).

Who can help prepare an FDA 510(k) submission like ARCPM 1050 RESIN-HIPS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ARCPM 1050 RESIN-HIPS

K023357 · Biomet Orthopedics, Inc. · LPH · Nov 6, 2002 · Orthopedic

Device Facts

Record ID	K023357
Device Name	ARCPM 1050 RESIN-HIPS
Applicant	Biomet Orthopedics, Inc.
Product Code	LPH · Orthopedic
Decision Date	Nov 6, 2002
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. Single use implant

Device Story

ArCom Polyethylene Liners and Components are acetabular hip joint implants. Manufactured from UHMWPE (GUR 1050) resin via isostatic compression molding. Designed to replace the articulating portion of the hip joint. Used by orthopedic surgeons in clinical settings for primary or revision hip arthroplasty. Implants function as the bearing surface in semi-constrained hip prostheses. Benefits include restoration of joint function and mobility in patients with degenerative joint disease or trauma. Device is single-use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including process validation (tensile, impact, physical properties), hip simulator testing, and aging/shelf-life studies.

Technological Characteristics

UHMWPE (GUR 1050) resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. Isostatically compression molded. Acetabular component form factor. Semi-constrained hip prosthesis. Cemented or non-cemented application.

Indications for Use

Indicated for skeletally mature patients requiring hip joint reconstruction due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision procedures, or nonunion/femoral neck/trochanteric fractures of the proximal femur. Use is cemented or non-cemented depending on specific component configuration.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

Ringloc UHMWPE Hi-Wall (K920640, K926107, K950761)
Ringloc UHMWPE 10° (K920640, K926107, K950761)
RX 90 std. Hi-Wall (K920639, K926107)
RX 90 +5 Deep (K920639, K926107)
Impact Hi-Wall (K921274)
Mod. Hi-Wall LNR (K926107)
Mod. 10° LNR (K926107)
Ringloc LP Hi-Wall Arcom (K950761)
Ringloc Arcom LP 10° (K950761)
Arcom +5mm (K954417, K970501)
Arcom Std. Face (K950761, K954417, K970501)
Arcom Hi-Wall (K950761, K954417, K970501)
Arcom 10° (K950761, K954417, K970501)
Arcom 10° Hi-Wall (K950761, K954417, K970501)

Related Devices

K052255 — ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS · Biomet, Inc. · Nov 23, 2005
K073150 — APEX-LNK POLY ACETABULAR CUP LINERS · Omni Life Science, Inc. · Feb 27, 2008
K021466 — CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE · Hayes Medical, Inc. · Jul 24, 2002
K062997 — ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS · Biomet Manufacturing Corp · Dec 8, 2006
K173583 — Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners · Exactech, Inc. · Mar 12, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 023357 BIOMET 6 2002 NOV # SUMMARY OF SAFETY AND EFFECTIVENESS | Sponsor: | Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Tracy J. Bickel (574) 267-6639 | | Proprietary Name: | ArCom® Polyethylene Liners and Components | | Common Name: | UHMWPE | | Classification Name: | -hip joint metal/polymer semi-constrained porous coated uncemented prosthesis (888.3358) -hip joint metal/polymer semi-constrained cemented prosthesis (888.3350) - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non- porous, uncemented (888.3353) | | Substantially Equivalent Devices: | Please see the attached page(s) for the specific equivalent devices. | | Device Description: | Biomet's polyethylene components are manufactured from UHMWPE (GUR 1050) resin conforming to ASTM F-648, ISO 5834-1, and ISO 5834-2. This resin is isostatically compression molded under constant temperature and pressure and formed into acetabular components, which are designed to replace the articulating portion of the hip joint. | | Indications for Use: | Please see the attached page(s) for the specific indications for use statements. | | Summary of Technologies: | The UHMWPE resin has been changed from 1900H to GUR 1050. The devices' technological characteristics (materials, design, sizing, and indications) are similar or identical to the predicate device. | | Non-Clinical Testing: | The following verification activities were performed on GUR 1050 resin: Process Validation (tensile, impact, and physical properties), Hip Simulator, Aging behavior and shelf life. All of which met or exceeded current standards or guidelines; therefore, substantially equivalent to the predicate device. | | Clinical Testing: | None provided as a basis for substantial equivalence. | All trademarks are property of Biomet, Inc. MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 1 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582 를 OFFICE 574.267.6639 E-MAIL blomet@biomet.com {1}------------------------------------------------ 比023357 p. 2 of 3 | SS&E Page 2 | |-------------------------------------------| | ArCom® Polyethylene Liners and Components | | 510(k) Number | Device Description | Indications for Use | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K920640 K926107 | Ringloc UHMWPE Hi-Wall 22, 26, 28, and 32 mm Ringloc UHMWPE 10° 22, 28, and 32mm | 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. Rheumatoid arthritis, 3. Correction of functional deformity, 4. Revision procedures where other treatments or devices have failed and 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. | | K920639 | RX 90 std. Hi-Wall 28mm RX 90 +5 Deep 28mm | For Cemented use only | | K921274 | Impact Hi-Wall 28 and 32mm | 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Revision procedures where other treatments or devices have failed and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Non-Cemented use only | | K926107 | Mod. Hi-Wall LNR 28 and 32mm Mod. 10° LNR 28 and 32mm RX 90 std. Hi-Wall 28mm RX 90 +5 Deep 28mm | 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. Rheumatoid arthritis, 3. Correction of functional deformity, 4. Revision procedures where other treatments or devices have failed and 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Cemented use only | | 510(k) Number | Device Description | Indications for Use | | K950761 | Ringloc UHMWPE Hi-Wall 22, 26, 28, and 32 mm Ringloc UHMWPE 10° 22, 28, and 32mm Ringloc LP Hi-Wall Arcom 22, 28, and 32mm Ringloc Arcom LP 10° 22, 28, and 32mm | 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2. Rheumatoid arthritis, 3. Correction of functional deformity, 4. Revision procedures where other treatments ordevices have failed and 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. | | K954417 | Arcom +5mm | For Cemented and Non-cemented use | | K950761 K954417 | Arcom Std. Face 28and 32mm Arcom Hi-Wall 22, 26, 28, and 32mm Arcom 10° 22, 26, 28, and 32 mm | | | | Arcom 10° Hi-Wall 28 and 32mm | | | K970501 | Arcom Std. Face 28 and 32mm Arcom Hi-Wall 22, 26, 28, and 32mm Arcom 10° 22, 26, 28, and 32 mm Arcom 10° Hi-Wall 28 and 32mm Arcom +5 28mm | Intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non- cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. Single use implant | {2}------------------------------------------------ 023357 SS&E Page 3 ArCom® Polyethylene Liners and Components {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on a single line and are evenly spaced. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 · Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587 Re: K023357 Trade/Device Name: ArCom® Polyethylene Liners and Components Regulation Number: See Enclosed List Regulation Name: See Enclosed List Regulatory Class: Class II Product Code: See Enclosed List Dated: October 4, 2002 Received: October 7, 2002 Dear Ms. Bickel: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 2002 If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ #### Page 2 - Ms. Tracy J. Bickel This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost Celia M. Witten, Ph.D., M.D. Director Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures (1) Indications for Use Forms (4 pages) (2) Classification Table (2 pages) {5}------------------------------------------------ EnclosurE : politici fi ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Product | Product Code | Classification Nomenclature | Class. Code | 510(k) | |-------------------------------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------| | Ringloc UHMWPE Hi-Wall 22, 26, 28, and 32 mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3358 888.3350 | K950761 | | Ringloc UHMWPE Hi-Wall 22, 26, 28, and 32 mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3350 | K920640 K926107 | | Ringloc UHMWPE 10° 22, 28, and 32mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3358 888.3350 | K950761 | | Ringloc UHMWPE 10° 22, 28, and 32mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3350 | K920640 K926107 | | Ringloc LP Hi-Wall Arcom 22, 28, and 32mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis JDI-hip joint metal/polymer semi-constrained cemented prosthesis | 888.3358 888.3350 | K950761 | | Ringloc Arcom LP 10° 22, 28, and 32mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3358 888.3350 | K950761 | | Arcom Std. Face 28and 32mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3358 888.3350 | K950761 K970501 K954417 | | Arcom Hi-Wall 22, 26, 28, and 32mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3358 888.3350 | K950761 K970501 K954417 | | Arcom 10° 22, 26, 28, and 32 mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3358 888.3350 | K950761 K970501 K954417 | | Arcom 10° Hi-Wall 28 and 32mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3358 888.3350 | K950761 K970501 K954417 | | Product | Product Code | Classification Nomenclature | Class. Code | 510(k) | | Arcom +5 28mm | LPH and JDI | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis | 888.3358 | K970501 | | | | JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3350 | K954417 | | Mod. Hi-Wall LNR 28 and 32mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3350 | K926107 | | Mod. 10° LNR 28 and 32mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3350 | K926107 | | RX 90 std. Hi-Wall 28mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3350 | K920639 K926107 | | RX 90 +5 Deep 28mm | JDI | JDI- hip joint metal/polymer semi-constrained cemented prosthesis | 888.3350 | K920639 K926107 | | Impact Hi-Wall 28 and 32mm | LZO LPH | LZO- prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 888.3353 888.3358 | K921274 | | | | LPH- hip joint metal/polymer semi-constrained porous coated uncemented prosthesis | | | {6}------------------------------------------------ Enclosure : . : ・ 2 L U + " : : {7}------------------------------------------------ Page 1 of 4. KU23357 510 (k) Number (if known) : Device Name: Arcom® Polyethylene Liners and Components Indications for Use: The products found in the original 510(k) K950761, and K954417 will use the following Indications for Use: - 1) NonInfiammatory degenerative joint disease including osteoarthritis and avascular necrosis, - 2) Rheumatoid arthritis, - 3) Correction of functional deformity, - 4) Revision procedures where other treatments or devices have failed and - 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head Involvement, unmanageable using other techniques. For Cemented and Non-cemented use #### (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _ (Per 21 CFR 801.109) OR Over-The-Counter-Use_ (Optional Format 1-2-96) {8}------------------------------------------------ Page 2 of 4. # 510 (k) Number (if known) : Device Name: Arcom® Polyethylene Liners and Components Indications for Use: The products found in the original 510(k) K920639, K920640 and K926107 will use the following Indications for Use: - 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - Rheumatoid arthritis, 2) - 3) Correction of functional deformity, - 4) Revision procedures where other treatments or devices have failed and - 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Cemented use only ## (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use_ (Optional Format 1-2-96) Muriam C. Provost (Division Sign Off) (Division Sien-Off) Division of General, Restorative and Neurological Devices 510(k) Number K023357 {9}------------------------------------------------ Page 3 of 4 #### 20233 510 (k) Number (if known) : Device Name: Arcom® Polyethylene Liners and Components Indications for Use: The products found in the original 510(k) K921274 will use the following Indications for Use: - 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - Rheumatoid arthritis, - Correction of functional deformity, - Revision procedures where other treatments or devices have falled and - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. For Non-Cemented use only ### (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) Muriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K023357 {10}------------------------------------------------ Page of 02335 510 (k) Number (if known) : Device Name: Arcom® Polyethylene Liners and Components Indications for Use: The products found in the original 510(k) K970501 will use the following Indications for Use: Intended for use in reconstruction of the hip joint due to disease, deformity of trauma The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant #### (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K023357